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Probing the Role of Sodium Channels in Painful Neuropathies

NCT02243475 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2014-09-18

No results posted yet for this study

Summary

Neuropathic pain is a frequent feature of peripheral neuropathy causing a significant impact on patients' quality of life and health care costs. Not all individuals with neuropathy develop pain and it is not possible to predict who is more or less susceptible among those with similar risk exposure. Current inability to identify high-risk individuals hinders development and application of therapies to counteract neuropathic pain and to address targeted prevention strategies. Recently, the investigators Consortium has identified novel pathogenic mutations in genes encoding for two sodium channels (Nav1.7 and Nav1.8) known to play a critical role in the generation and conduction of action potentials in nociceptors and their terminal axons. This study was undertaken in a carefully selected group of patients with painful neuropathy using a candidate gene approach and directly revealed targets for new therapeutic strategies. This discover widened the spectrum of sodium channel-related pain disorders including conditions more common in the general population than those known so far. PROPANE STUDY, starting from the hypothesis of a common origin of neuropathic pain in a cohort of patients with predominantly small fibre neuropathy, aims to develop this original idea in a larger and well characterized study population, to provide evidence for the reliable stratification of patients at high risk and potential new treatments tailored on patients' clinical features, in order to improve their quality of life.

Conditions

  • Painful Peripheral Neuropathy
  • Painless Peripheral Neuropathy

Sponsors & Collaborators

  • Maastricht University

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • University of Manchester

    collaborator OTHER

  • Deutsche Diabetes Gesellschaft

    collaborator OTHER

  • Centre National de la Recherche Scientifique, France

    collaborator OTHER

  • Ospedale San Raffaele

    collaborator OTHER

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    lead OTHER

Principal Investigators

  • Giuseppe Lauria, MD · FINCB

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02243475 on ClinicalTrials.gov